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1.ǰ
1.1ָƶΣP(gun)Ic(din)HACCPĻԭt(sh)ʩָ(do)ԎʳƷI(y)ʳƷȫĹˮƽCʳƷl(wi)|(zh)So(h)M(fi)档HACCPľw(sh)ʩ(yng)Y(ji)ʳƷI(y)a(chn)(jng)IČ(sh)Hr;wl
1.2HACCPԑ(yng)(g)ʳƷ(yng)-ij(j)(ԭ)a(chn)KM(fi)ґ(yng)ԽΣ ĿƌW(xu)(j)錧(do)M(jn)Ќ(sh)ʩHACCPČ(sh)ʩ߀ʳƷȫıO(jin)ͨ^ ʳƷȫĿŶȴM(jn)(jng)(j)l(f)չ
1.3 HACCPijɹ(sh)ʩҪI(y)ӼСMijֺ֧ͅcHACCPČ(sh)ʩ|(zh) wϵISO9000ϵУ|(zh)wϵ¹ʳƷȫһNϵy(tng)
1.4 ҹĄ(l)ʳƷI(y)X(sh)ʩHACCPѽ(jng)(sh)ʩHACCPI(y)M(jn)ָ(do)ur(ji)
2.HACCP
20o(j)60ʳƷa(chn)cҎ(gu)״νHACCPϵy(tng)1993HʳƷίT(hu)CAC]HACCPϵy(tng)ĿǰʳƷȫ(jng)(j)Ч;
HACCPԿƌW(xu)A(ch)ͨ^ϵy(tng)Եش_wΣƴʩԱCʳƷȫԵϵy(tng)HACCPĿϵy(tng)A(y)Ka(chn)Ʒęz(yn)CʳƷİȫκһ(g)HACCPϵy(tng)m(yng)O(sh)O(sh)Ӌ(j)ĸӹˇg(sh)İl(f)չ׃HACCPһ(g)mڸʳƷI(y)ĺСЧĿwϵ
3.x
ָ漰g(sh)Zx£
3.1Σ(Hazard Analysis)ָռuP(gun)ΣԼ(do)@ЩΣڵY Դ_ЩΣʳƷȫҪӰҪHACCPӋ(j)ԽQ^
3.2P(gun)Ic(din)Critical Control Point, CCPָ܉?q)ʩƴʩIJE ԓEA(y)һ(g)ʳƷȫΣ?q)pٵɽˮƽdzP(gun)I
3.3 Prerequisite Programs錍(sh)ʩHACCPwϵṩA(ch)IJҎ(gu) a(chn)Ҏ(gu)GMPl(wi)(bio)(zhn)SSOP
3.4a(chn)Ҏ(gu)Good Manufacture Practice, QGMPǞ鱣ʳƷȫ|(zh) ƶ؞ʳƷa(chn)ȫ^һϵдʩͼg(sh)ҪҪʳƷa(chn)I(y)(yng)߂õa(chn)O(sh)a(chn)^Ƶ|(zh)͇(yn)ęzyϵy(tng)_Ka(chn)Ʒ|(zh)Ϙ(bio)(zhn)
3.5 l(wi)(bio)(zhn)Sanitation Standard Operating ProcedureQSSOP ʳƷI(y)鱣ʳƷl(wi)|(zh)ʳƷӹ^Б(yng)صIJҎ(gu)wɰ·ˮ|(zh)ȫʳƷ|ėl坍ֹȾϴl(wi)gO(sh)ʩľSo(h)ֹsƷжW(xu)Ę(bio)ӛAʹ͆TĽrxcơ
3.6 HACCPСMHACCP team ؓ(f)؟(z)ƶHACCPӋ(j)ĹСM
3.7 ̈D(Flow Diagram): ָij(g)wʳƷӹa(chn)^̵вEM(jn)еBm(x)
3.8 Σ(Hazard): ָНڲӰ푵W(xu)ػl
3.9@Σ(Significant Hazard)пܰl(f)ҿ܌M(fi)ߌ(do)²ɽܵΣаl(f)ĿԺ͇(yn)
3.10 HACCPӋ(j)HACCP Plan(j)HACCPԭtƶһļڴ_ʳƷ a(chn)ӹN۵ʳ朸AcʳƷȫҪP(gun)ϵΣõơ
3.11 EStepָĮa(chn)ƷӹKM(fi)ʳУԭڃ(ni)һ(g)c(din) һ(g)һ(g)һ(g)AΡ
3.12 ƣControl, (dng)~鱣CͱHACCPӋ(j)ĿƘ(bio)(zhn)ȡ Ҫʩ
3.13 ƣControl, ~ָ(zh)_IJϿƘ(bio)(zhn)Ġr
3.14 c(din)Control Point, CPܿW(xu)صκc(din)E ^
3.15 P(gun)Ic(din)ж(CCP Decision Tree)ͨ^һϵІ}Дһ(g)c(din)Ƿ P(gun)Ic(din)ĽMD
3.16 ƴʩControl Measureָ܉A(y)һ(g)ʳƷȫΣ,?q)併͵?nbsp;ɽˮƽκδʩЄ(dng)
3.17 P(gun)Iֵ(Critical Limits)^(q)ֿɽܺͲɽˮƽĘ(bio)(zhn)ֵ
3.18 ֵ(Operating Limits)P(gun)Iֵ(yn)ɲÁpƫx L(fng)U(xin) Ę(bio)(zhn)
3.19 ƫ(Deviation) ָδܷP(gun)Iֵ
3.20 mƫʩCorrective Action(dng)ᘌP(gun)Ic(din)CCPıO(jin)y@ʾԓP(gun)I c(din)ʧȥƕr(sh)ȡĴʩ
3.21 O(jin)yMonitoruP(gun)Ic(din)CCPǷõָ(bio)M(jn)Ӌ(j) Bm(x)^zy
3.22 _J(rn)ValidationC(sh)HACCPӋ(j)иҪЧ
3.23 (yn)CVerificationָ˴_HACCPӋ(j)Ƿ_(sh)ʩõijO(jin)y ԇ(yn)ur(ji)
4.a(chn)Ҏ(gu)GMP
4.1ʳƷ(sh)ʩGMP(yng)ѽ(jng)l(f)P(gun)a(chn)Ҏ(gu)Դ_ӹa(chn)ƷO(sh)ʩͿǷȫԼ@Щa(chn)ƷǷl(wi)l¼ӹ
4..2I(y)(yng)ԓ(sh)ʩGMPrM(jn)Йzӛ䛣ӛrn
5.l(wi)(bio)(zhn)SSOP
5.1ÿ(g)I(y)(yng)ƶ͌(sh)ʩl(wi)(bio)(zhn)ļfI(y)ΝM͌(sh)ʩl(wi)lҎ(gu)
5.1.1 cʳƷʳƷ|ˮİȫԻa(chn)ñİȫ
5.1.2 ʳƷ|棨O(sh)µȣl(wi)r坍ȣ
5.1.3 ֹl(wi)ƷʳƷʳƷbcʳƷ|Ⱦδӹa(chn)Ʒ ƷĽȾ
5.1.4 ϴgO(sh)ʩ͎O(sh)ʩl(wi)r
5.1.5 ֹʳƷʳƷbϺʳƷ|擽sȼϡx坍 W(xu)Ⱦ
5.1.6 Ҏ(gu)Ę(bio)ʾ(bio)惦(ch)ʹж
5.1.7 T(g)l(wi)Ŀ@Щl(wi)l܌ʳƷʳƷbϺʳƷ|a(chn) Ⱦ
5.1.8 繤S(ni)x
5.2ÿ(g)I(y)(yng)ԓ(sh)ʩSSOPrM(jn)Йzӛ䛣ӛ䛽Y(ji)n
6.HACCPԭt
HACCPӋ(j)7(g)ԭt
ԭt1M(jn)Σ
ԭt2_P(gun)Ic(din)CCPs
ԭt3ӆP(gun)Iֵ
ԭt4O(jin)ywϵԱO(jin)yÿ(g)P(gun)Ic(din)Ŀr
ԭt5(dng)P(gun)Ic(din)ʧȥƕr(sh)(yng)ȡļmƫʩ
ԭt6_J(rn)HACCPϵy(tng)Ч\(yn)е(yn)C
ԭt7P(gun)ԭt䑪(yng)õıҪӛ䛡
7.HACCPӋ(j)(sh)ʩ^
7.1MHACCPСM
7.1.1HACCPСMؓ(f)؟(z)ƶHACCPӋ(j)Լ(sh)ʩ(yn)CHACCPwϵHACCPСMˆT(gu)ɑ(yng)CЧHACCPӋ(j)P(gun)I(y)֪R(sh)ͽ(jng)(yn)(yng)I(y)wHACCPӋ(j)(sh)ʩI(lng)(do)a(chn)g(sh)ˆT̼g(sh)ˆT|(zh)ˆTԼҪˆTg(sh)IJСI(y)Ƹҡ
7.1.2 (yng)_HACCPӋ(j)ķʳƷ(yng)еľw(sh)ʩh(hun)(ji)Լ횼ԽQΣ һexؽQΣ}߀ǽQеΣ}
7.2a(chn)Ʒ_a(chn)ƷA(y);
HACCPҪ΄(w)nj(sh)ʩHACCPϵy(tng)Įa(chn)ƷM(jn)ă(ni)ݰ
7.2.1 a(chn)ƷQfa(chn)^ͣ
7.2.2 a(chn)ƷԭϺҪɷ
7.2.3 a(chn)Ʒ|(zh)awpHȣ̎ӹ}nѬƵȣ
7.2.4 bʽ
7.2.5 Al
7.2.6 |(zh)
7.2.7 N۷ʽ
7.2.8 Nۅ^(q)
7.2.9 Ҫr(sh)P(gun)ʳƷȫвW(xu)Y
7.2.10 a(chn)ƷA(y);M(fi)Ⱥ
7.3Lƺʹ_J(rn)a(chn)ˇ̈D
HACCPСM(yng)a(chn)Ԕ(x)˽a(chn)Ʒa(chn)ӹ^ڴ˻A(ch)LƮa(chn)Ʒa(chn)ˇ̈DɺҪF(xin)(yn)C̈D
7.4Σ
7.4.1Σɷ֞(xing)(dng)ӑՓΣur(ji)ӑՓr(sh)ҪVȫ棬Ҫõԭa(chn)ƷӹÿһEO(sh)䡢Ka(chn)Ʒ䃦(ch)ͷNʽһֱM(fi)ʹîa(chn)ƷȵڴAҪMгпܳF(xin)ĝΣ]аl(f)ɵΣ(hu)HACCPӋ(j)M(jn)һ]ӑՓСMÿһ(g)Σl(f)ĿԼ(yn)س̶M(jn)ur(ji)Դ_ʳƷȫdzP(gun)I@Σ(L(fng)U(xin)Ժ͇(yn)){HACCPӋ(j)
7.4.2M(jn)Σr(sh)(yng)ȫ}cһ|(zh)}^(q)_(yng)]漰ȫ}Σ
7.4.2.1Σ (x)䶾xк
7.4.2.2W(xu)Σ
W(xu)Σɷ֞ȻĻW(xu)|(zh)ĻW(xu)ƷożȻĻW(xu)Ʒa(chn)^a(chn)кW(xu)|(zh)
ȻĻW(xu)|(zh)ùMȡ
ĻW(xu)ƷʳӄIB(yng)ӄɫӄ
ożȻĻW(xu)ˎƷr(nng)I(y)ϵĻW(xu)ˎƷ|(zh)ж|(zh)ͻSW(xu)|(zh)坍ȣ
7.4.2.3ΣκΝʳƷвl(f)F(xin)к粣ٵ
7.4.3 гΣ
ΣοÁM_Σ˼·HACCPСM߀(yng)]ÿһΣɲȡķNƴʩ
7.5_P(gun)Ic(din)
P(gun)Ic(din)ָȥΣΣl(f)ʵһ(g)c(din)Ea(chn)еκһ(g)Aԭ䷽Լ()a(chn)ճ\(yn)ݔ{(dio)ӹ̓(ch)^ÿ(g)a(chn)@Σc(din)EδضP(gun)Ic(din)_P(gun)Ic(din)Ŀʹһ(g)ڵʳƷΣA(y)pٵԽ ˮƽ_P(gun)Ic(din)߀ҪO(sh)l(f)ڸ(g)P(gun)Ic(din)ΣĿɽܵˮƽ
(yng)ж߉_HACCPϵy(tng)еP(gun)Ic(din)CCPжđ(yng)Ñ(yng)(dng)`Ҫr(sh)Ҳʹķ
ijһEόһ(g)_ΣM(jn)пƌCʳƷȫDZҪȻԓEE϶](yng)ĿƴʩôԓEԓǰIJEa(chn)ӹˇM(jn)Աʹ(yng)Ŀƴʩ
7.6ÿ(g)P(gun)Ic(din)P(gun)Iֵ
ÿ(g)P(gun)Ic(din)(hu)һ(xing)(xing)ƴʩ_A(y)Ѵ_@Σ?q)pɽܵˮƽÿһ(xing)ƴʩҪһ(g)(yng)P(gun)Iֵ
P(gun)IֵĴ_(yng)ԿƌW(xu)(j)ɁԴڿƌW(xu)Ҏ(gu)ָҡԇ(yn)оȵÁ_P(gun)Iֵ(j)ͅYϑ(yng)HACCP֧ļһ֡
ͨP(gun)Iʹõָ(bio)ضr(sh)gȡpHˮֻ}텢(sh)ɵζЧȡӄԼйָ(bio)^͚ζ
7.7ÿ(g)P(gun)Ic(din)M(jn)бO(jin)yϵy(tng)
ͨ^O(jin)y܉l(f)F(xin)P(gun)Ic(din)Ƿʧءͨ^O(jin)y߀ṩҪϢԼr(sh){(dio)a(chn)^ֹ̣P(gun)Iֵ
ֵDZP(gun)Iֵ(yn)ֵɲˆTʹԽƫxL(fng)U(xin)Ę(bio)(zhn)ӹ(yng)(dng)ڳ^ֵr(sh)M(jn){(dio)Ա`P(gun)Iֵ@ЩʩQӹ{(dio)ӹˆTʹ@Щ{(dio)ʩʧغͱȡmƫЄ(dng)l(f)F(xin)ʧصڅݣȡЄ(dng)Էֹa(chn)Ʒ߸ĵrɮa(chn)Ʒ(bo)UֻڳP(gun)Iֵr(sh)ŲȡmƫЄ(dng)
һ(g)O(jin)ϵy(tng)O(sh)Ӌ(j)횴_
7.7.1O(jin)(ni)ݣͨͨ^^͜yuһ(g)CCPIJǷP(gun)Iֵ(ni)
7.7.2O(jin)طO(sh)Ӌ(j)ıO(jin)شʩ܉ṩY(ji)ͻW(xu)zy܉zyܿM(jn)ǺܺõıO(jin)طõW(xu)O(jin)yָ(bio)r(sh)g͜ضȽMϣÁO(jin)ؚƲԭwLЧ̶ȣˮֻȣaWͨ^ˮֻȁƲԭwL˿ռƷzyˮֻȻPHֵһPHֵˮƽƲԭwLйٙz(yn)һNzyʳƷֱ^
7.7.3O(jin)O(sh)䣺؝Ӌ(j)犱ƽPHӋ(j)ˮֻӋ(j)W(xu)O(sh)
7.7.4O(jin)lʣO(jin)ؿBm(x)ĻBm(x)ģп(yng)ȡBm(x)O(jin)Bm(x)O(jin)،SW(xu)(sh)ǿеġO(jin)yBm(x)M(jn)еôO(jin)yĔ(sh)lʑ(yng)_P(gun)Ic(din)ڿ֮
7.7.5O(jin)ˆTM(jn)CCPO(jin)صˆTˮϵˆTO(sh)O(jin)TSˆT|(zh)CˆTȵؓ(f)؟(z)O(jin)CCPˆT횽P(gun)CCPO(jin)ؼg(sh)Ӗ(xn)ȫCCPO(jin)صҪܼr(sh)M(jn)бO(jin)ػ(dng)(zhn)_(bo)ÿαO(jin)عSr(sh)(bo)`P(gun)IֵrԱ㼰r(sh)ȡmƫ(dng)
7.8mƫʩ
7.8.1HACCPӋ(j)ÿһ(g)P(gun)Ic(din)(yng)A(y)Ƚ(yng)ļmƫʩԱڳF(xin)ƫxr(sh)(sh)ʩ
7.8.2mƫʩ(yng)1_mƫxԭ2_ƫx漰a(chn)Ʒ̎M(jn)иxͱ沢ȫu˻ԭ¼ӹNa(chn)Ʒȣ3ӛ䛼mƫЄ(dng)a(chn)Ʒ_J(rn)a(chn)Ʒ̎îa(chn)ƷĔ(sh)ƫxȡļmƫЄ(dng)Ӱ푮a(chn)ƷK̎ȡmƫЄ(dng)ˆTҪuY(ji)
7.9(yn)C
ͨ^(yn)Cz(yn)SC(j)ӻ(yn)ɴ_HACCPǷ_\(yn)(yn)CCCP(yn)C͌HACCPwϵ(yn)C
7.9.1 CCP(yn)C(dng)
7.9.1.1 У(zhn)CCP(yn)C(dng)O(jin)O(sh)У(zhn)Դ_ȡĜyĜ(zhn)_
7.9.1.2 У(zhn)ӛ䛵ď(f)飺(f)O(sh)У(zhn)ӛO(sh)Ӌ(j)zںУ(zhn)Լ(sh)(yn)Y(ji) (yng)ԓУ(zhn)ӛ䛲ԏ(f)
7.9.1.3 ᘌԵIJɘәzy
7.9.1.4 CCPӛ䛵ď(f)
7.9.2 HACCPwϵ(yn)C
7.9.2.1(yn)Clʣ(yn)Clʑ(yng)Դ_J(rn)HACCPwϵЧ\(yn)УÿM(jn)һλϵy(tng)l(f)ϕr(sh)a(chn)Ʒԭϻӹ^̰l(f)@׃r(sh)l(f)F(xin)µΣr(sh)M(jn)
7.9.2.2wϵ(yn)C(dng)za(chn)Ʒfa(chn)̈DĜ(zhn)_zCCPǷHACCPҪO(jin)O(jin)ػ(dng)ǷHACCPӋ(j)Ҏ(gu)Ĉ(zh)O(jin)ػ(dng)ǷHACCPӋ(j)Ҏ(gu)lʈ(zh)У(dng)O(jin)رl(f)ƫxP(gun)IƵrr(sh)Ƿ(zh)˼mƫЄ(dng)O(sh)ǷHACCPӋ(j)Ҏ(gu)lM(jn)У(zhn)ˇ^ǷڼȶP(gun)Iֵ(ni)zӛǷ(zhn)_ǷҪĕr(sh)gɵȵ
7.10ļӛ䛙n
һvHACCPwϵ횱ӛ䛑(yng)
7.10.1ΣСY(ji)ΣκM(jn)ΣͽP(gun)IֵκϢӛ֧ļҲƶƼ(x)ԲԭwLķr(sh)ʹõijYa(chn)Ʒȫ؛܉ʹõYԼڴ_(x)ԲԭwӟᏊ(qing)ȕr(sh)ʹõYϡ˔(sh)(j)֧ļҲP(gun)͌M(jn)ԃż
7.10.2 HACCPӋ(j)HACCPСMμP(gun)؟(z)a(chn)Ʒ(jng)_J(rn)a(chn)ˇ̺HACCPСY(ji)HACCPСY(ji)(yng)a(chn)ƷQCCP̎IJEΣQP(gun)IֵO(jin)شʩmƫʩ(yn)Cͱӛ䛵ij
7.10.3 HACCPӋ(j)(sh)ʩ^аl(f)ӛ䛡
7.10.4 ֧ļ(yn)CӛHACCPӋ(j)ӆ
8.cӖ(xn)
8.1l(wi)T(hu)M(jn)HACCP֪R(sh)̹
8.2l(wi)g(sh)ˆTʳƷI(y)(yng)ڌϵy(tng)(ni)P(gun)ˆTM(jn)HACCPӖ(xn)
9
9.1ʳƷI(y)(yng)(sh)ʩHACCPM(jn)I(y)ĻA(ch)O(sh)ʩg(sh)Y(ji)
9.2HACCPᘌwĮa(chn)Ʒa(chn)ˇģa(chn)ˇ׃I(y)(yng)ԓY(ji)ό(sh)HrHACCPIJփ(ni)M(jn)
9.3ָϸṩһϵP(gun)HACCPӋ(j)ıI(y)(sh)ʩHACCPr(sh)@Щ(ni)ݵľwʽ`ҲЙC(j)Y(ji)ϵI(y)F(xin)|(zh)wϵľw(sh)ʩļ
ʳƷI(y)HACCP(sh)ʩָϸd |